The Lyra Direct C. difficile Assay is a qualitative, multiplexed in vitro diagnostic test for the detection of toxin A gene (tcdA) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile-Associated Disease (CDAD).
A multiplex real-time PCR reaction is performed under optimized conditions in a single well generating amplicons for each of the targets present in the sample. Identification occurs by the use of oligonucleotide primers and probes that are complementary to conserved regions in the tcdA and tcdB genes of the pathogenicity locus.
The Lyra Direct C. difficile Assay has one-step reagent set-up and a three-step sample prep. Test results are available in less than 70 minutes. Lyra Direct C. difficile is a quality real-time PCR available for use on Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument, QuantStudioTM Dx Real-Time PCR Instrument and Cepheid® SmartCycler® II.
The Lyra Direct C. difficile test is one in a growing menu of real-time PCR assays and intended to aid in the diagnosis of CDAD in humans.
Features & Benefits
| Feature | Benefit |
|---|---|
One-step reagent set-up | Rehydration solution is simply added to the lyophilized Master Mix |
Speed | Results in less than 70 minutes |
Easy training | Simplified and uniform workflow with standard pipetting volumes |
Refrigerated storage | No freezer needed. 2°C to 8°C storage |
Long shelf life | 2 years from date of manufacture |
Room temperature set up | No ice or cooling block required |
Flexible 96-test format | Kit includes vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls. Sample preparation kit includes all consumables |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
Sample type | Unformed (liquid or soft) stool samples |
Time to results | Less than 70 minutes |
Reagent storage conditions | 2°C to 8°C |
Controls storage conditions | 2°C to 8°C |
Sample preparation storage conditions | 2°C to 25°C |
Sensitivity* | 94.3% AB 7500 Fast Dx, 93.3 % QuantStudio Dx; 89.7% Smart Cycler II |
Specificity* | 94.2% AB 7500 Fast Dx; 93.4% QuantStudio Dx; 93.3% SmartCycler II |
LOD | 0.2 to 1 CFU |
Processed sample needed to test | 5 µL |
Shelf life | 24 months |
*Refer to Package Insert for additional performance claims.
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M105 | Assay Kit | 96 tests |
M207 | Sample Preparation Kit | 96 tests |
M108 | Quidel Molecular C. difficile Control Set | 40 reactions |
Product Documentation
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To better serve your molecular diagnostic needs Quidel offers two instruments
